Otrivin with menthol and eucalyptus

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT Otrivin with menthol and eucalyptus (Otrivin with menthol and eucalyptus)

Composition:

Active ingredient: xylometazoline hydrochloride;

1 ml of solution contains xylometazoline hydrochloride 1 mg;

Excipients: sodium dihydrogen phosphate dihydrate; sodium hydrogen phosphate dodecahydrate; sodium chloride; benzalkonium chloride; disodium edetate; menthol; eucalyptol; sorbitol (E 420); polyethylene glycol castor oil hydrogenated; purified water.

Pharmaceutical form. Nasal spray, metered.

Main physicochemical properties: clear or opalescent solution, colorless to whitish.

Pharmacotherapeutic group. Preparations used in nasal cavity disorders. Decongestants and other agents for local use in nasal disorders. Simple sympathomimetics. ATC code R01A A07.

Pharmacological properties.

Pharmacodynamics.

Xylometazoline is a sympathomimetic agent acting on α-adrenergic receptors.

When applied intranasally, xylometazoline causes vasoconstriction of the blood vessels in the nasal mucosa and adjacent areas of the nasopharynx, thereby reducing swelling and hyperemia of the nasal and nasopharyngeal mucosa. It also decreases associated excessive mucus secretion and facilitates clearance of blocked nasal secretions, resulting in opening of the nasal passages and improved nasal breathing.

The effect of the drug begins within 2 minutes after administration and lasts up to 12 hours.

The drug is well tolerated, including by patients with sensitive mucosa, and does not impair mucociliary function. Laboratory analyses have shown that xylometazoline reduces the infectious activity of human rhinovirus associated with the common cold.

The preparation contains evaporating cooling aromatic substances – menthol and eucalyptol.

Pharmacokinetics.

After topical application, the drug is practically not absorbed, and plasma concentrations of xylometazoline are so low that they are practically undetectable (plasma concentration is close to the limit of detection).

Xylometazoline has no mutagenic properties. Also, studies in animals have not revealed any teratogenic effects of xylometazoline.

Clinical characteristics.

Indications.

Symptomatic treatment of nasal congestion due to colds, hay fever, other allergic rhinitis, and sinusitis.

To facilitate drainage of secretions in diseases of the nasal accessory sinuses.

Adjunctive therapy in cases of otitis media (to relieve mucosal swelling).

To facilitate rhinoscopy.

Contraindications.

Hypersensitivity to xylometazoline, to any of the excipients, or to other sympathomimetic amines; closed-angle glaucoma, transsphenoidal hypophysectomy, and transnasal or transoral surgical procedures exposing the meninges or history thereof; atrophic rhinitis (rhinitis sicca). Patients receiving concomitant treatment with monoamine oxidase inhibitors (see section "Interaction").

Interaction with other medicinal products and other forms of interaction.

Monoamine oxidase inhibitors (MAO inhibitors): xylometazoline may potentiate the effect of monoamine oxidase inhibitors and induce a hypertensive crisis. Do not use xylometazoline in patients taking or who have taken MAO inhibitors within the previous two weeks.

Tricyclic and tetracyclic antidepressants: concomitant use of tricyclic or tetracyclic antidepressants and sympathomimetic agents may enhance the sympathomimetic effect of xylometazoline; therefore, concomitant use of these agents is not recommended.

Concomitant use with β-blockers may cause bronchospasm or reduction in blood pressure.

Special precautions for use.

The drug should not be used for more than 5 consecutive days.

Prolonged or excessive treatment with xylometazoline may cause secondary swelling of the nasal mucosa, with a risk of chronic rhinitis and/or atrophy of the nasal mucosa.

Like other sympathomimetics, the drug should be prescribed with caution to patients who exhibit strong reactions to adrenergic agents, manifested as insomnia, dizziness, tremor, cardiac arrhythmia, or increased blood pressure.

The recommended dose of the drug should not be exceeded, especially when treating children and elderly patients.

The drug should be prescribed with caution to patients with cardiovascular diseases, arterial hypertension, diabetes mellitus, hyperthyroidism, pheochromocytoma, or benign prostatic hyperplasia. It should not be used in patients who have received concomitant treatment with monoamine oxidase inhibitors (MAOIs) or within 2 weeks after discontinuation of such therapy.

Patients with long QT syndrome who receive xylometazoline may have an increased risk of serious ventricular arrhythmias. Nasal irrigation with physiological saline is recommended as first-line therapy. Otrivin with menthol and eucalyptus may be used as a second-line medicinal product.

The drug contains benzalkonium chloride (0.014 mg of benzalkonium chloride per 0.14 mL dose, equivalent to 0.100 mg/mL), which may cause nasal mucosal swelling, particularly with prolonged use.

Cases of posterior reversible encephalopathy syndrome (PRES) / reversible cerebral vasoconstriction syndrome (RCVS) have been reported with the use of sympathomimetic drugs. Reported symptoms include sudden severe headache, nausea, vomiting, and visual disturbances. In most cases, symptoms improved or resolved within a few days after appropriate treatment. The drug should be discontinued immediately and medical advice sought if signs/symptoms of PRES/RCVS develop.

Use during pregnancy or breastfeeding.

The drug should not be used during pregnancy due to its potential vasoconstrictive effect. There is no evidence of any adverse effect on the infant. It is unknown whether xylometazoline is excreted in breast milk; therefore, caution is necessary, and the drug should be used during breastfeeding only on medical advice. Prolonged use should be avoided during breastfeeding due to the risk of adverse effects in the infant (tachycardia, excitation, increased blood pressure).

Fertility.

There are no adequate data on the effect of Otrivin with menthol and eucalyptus on fertility. Since systemic exposure to xylometazoline hydrochloride is very low, the likelihood of an effect on fertility is extremely low.

Ability to affect reaction speed when driving or operating machinery.

The drug usually has no effect or has a negligible effect on the ability to drive vehicles or operate machinery. However, with excessively prolonged use or use at high doses, an effect on the cardiovascular system cannot be excluded.

Method of Administration and Dosage

The medication should be administered to adults and children aged 12 years and older as 1 spray into each nostril, up to 3 times daily. Do not administer more than 3 times into each nostril per day. The interval between administrations should be at least 8–10 hours. The duration of treatment depends on the course of the illness and should not exceed 5 consecutive days.

Do not cut off the spray nozzle. The nasal spray is a metered dose formulation and is ready for immediate use.

The metered-dose spray ensures accurate dosing and proper distribution of the solution over the nasal mucosal surface. Each spray delivers 0.14 mL of solution, corresponding to 0.14 mg of xylometazoline.

Before first use, prime the spray pump by pressing it 4 times. After this, the spray pump will be ready for use throughout the entire treatment period. If the spray does not dispense when the pump is pressed, or if the medication has not been used for more than 7 days, re-prime the spray pump by actuating it 4 times into the air.

The spray should be used as follows:

• thoroughly clean the nose before applying the medication;
• hold the bottle vertically, supporting the bottom with the thumb and positioning the nozzle between two fingers;
• slightly tilt the bottle and insert the nozzle into the nostril;
• administer the spray while simultaneously taking a gentle nasal inhalation;
• after use, before replacing the cap, clean and dry the nozzle;
• to prevent infection, each bottle of medication should be used by only one person.

The last administration is recommended to be performed immediately before bedtime.

Children

The medication should not be used in children under 12 years of age.

Overdose

Excessive local use of xylometazoline hydrochloride or accidental ingestion may lead to pronounced dizziness, sweating, significant decrease in body temperature, headache, bradycardia, less commonly tachycardia, arterial hypertension, respiratory depression, coma, and seizures. Elevated arterial pressure may be followed by hypotension. Impaired consciousness may indicate severe intoxication. Younger children are more sensitive to the toxic effects than adults. At home, activated charcoal may be administered as emergency first aid prior to hospitalization.

In cases of severe intoxication, hospitalization is required and emergency symptomatic treatment must be administered under medical supervision. Medical care should include monitoring of the patient's condition for several hours. In cases of severe overdose accompanied by cardiac arrest, resuscitation measures should continue for at least 1 hour.

Adverse reactions.

Adverse reactions are classified by frequency of occurrence into the following categories: very common (≥ 1/10), common (≥1/100 – <1/10), uncommon (≥ 1/1000 – <1/100), rare (≥ 1/10,000 – < 1/1000), very rare (< 1/10,000).

Immune system disorders:

very rare: hypersensitivity reactions, including angioedema, rash, pruritus.

Nervous system disorders:

common: headache; uncommon: insomnia.

Eye disorders:

very rare: transient visual disturbances.

Cardiac and vascular disorders:

very rare: irregular or rapid heartbeat, arterial hypertension, arrhythmia.

Respiratory, thoracic and mediastinal disorders:

common: dryness or discomfort of the nasal mucosa, burning sensation; drug-induced rhinitis; uncommon: epistaxis.

Gastrointestinal disorders:

common: nausea; uncommon: vomiting.

General disorders and administration site conditions:

common: burning sensation at the application site.

Reporting of adverse reactions after marketing authorization is important. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals and patients or their legal representatives are encouraged to report all suspected adverse reactions and lack of efficacy via the automated pharmacovigilance information system at: https://aisf.dec.gov.ua.

Shelf life. 2.5 years.

Storage conditions. Store out of reach of children at a temperature not exceeding 25 °C.

Packaging. 10 ml in a bottle with spray dispenser. 1 bottle per cardboard box.

Pharmaceutical category. Over-the-counter (without prescription).

Manufacturer. Haleon CH S.a.r.l. / Haleon CH S.a.r.l.

Manufacturer's address and place of business.

Route de l’Etraz 2, Nyon, 1260, Switzerland / Route de l’Etraz 2, Nyon, 1260, Switzerland.